Inflammatory conditions of the gastro-intestinal tract often cause severe discomfort, abdominal pain and diarrhoea to suffers. Further, persons with these conditions often have an impaired ability to take up nutrients. This is particularly serious in children where it can lead to stunted growth and poor weight gain. Examples of these conditions are Crohn's disease, ulcerative colitis, and certain infectious diseases such as AIDS. Of these conditions, Crohn's disease is particularly troublesome. The disease may cause severe abdominal pain and nutritional problems. Also, the disease has a high relapse rate after treatment. For example, in children, Crohn's disease has a chronic relapsing course in which up to 50% of the patients eventually need surgery (Davies, G et al; 1990; Br. J. Surg.; 77: 81-94).
Treatment of Crohn's disease using corticosteroid therapy is found to induce remission and is a treatment which is often used. However, corticosteroid therapy has undesirable side effects; particularly in children where growth is adversely affected. Cyclosporin has also been attempted in the treatment of Crohn's disease but the side effects of Cyclosporin are particularly severe; especially on renal function and reduced immune response.
Consequently, there has been considerable interest in the use of nutritional therapy in the treatment or prophylaxis of Crohn's disease. In particular, the semi-elemental formula, Flexical.RTM. (Mead Johnson), has been shown to be as effective as the steroid prednisolone (Sanderson et al; 1987; Arch. Dis. Child.; 51: 123-7). Since the publication of this report, Flexical.RTM., and other similar semi-elemental formulas, have often been used as a primary therapy in Crohn's disease. However, semi-elemental formulas, which are based upon hydrolysed protein, are relatively expensive and often suffer from palatability problems. This has restricted their use.
Attempts have therefore been made to use whole protein in nutritional therapy of Crohn's disease. However, the treatment has not been universally successful (Giafer et al; 1990; Lancet; 335:816-9). To improve the efficacy of the formulas, efforts have recently focused on the type of protein used in the formulas. For example, U.S. Pat. No. 5,461,033 describes the use of an acid casein fraction, which is isolated from bovine milk and which contains TGF-.beta.2, in the treatment of Crohn's disease. The data reported in the patent are based upon in vitro experimentation and the patent gives no specific description of nutritional formulas which may be used in the treatment of Crohn's disease. However, Beattie et al (1994; Aliment. Pharmacol. Ther.; 8: 1-6) have reported the use of the acid casein fraction in an infant formula in the treatment of 7 children with active small bowel Crohn's disease. The energy content of the formulation was 700 Kcal/l, the osmolality was 150 mOsm/l, the protein content was 15% of energy, the lipid content was 31% of energy and the carbohydrate content was 54% of energy.
Although the study was an uncontrolled, descriptive study, the results were very positive. All children showed significant improvement after 8 weeks of treatment. C-reactive protein returned to normal, serum albumin increased and the children increased in weight. Further, ideal biopsies indicated that 6 of the 7 children had reduced mucosal inflammation with 2 of the 6 children having complete healing. However, apart from the acid casein fraction, the enteral formula was an infant formula and not specifically targeted to patients with inflammatory conditions of the gastro-intestinal tract.
Therefore there is a need for an enteral composition which is based upon whole protein, which is targeted to patients which inflammatory conditions of the gastro-intestinal tract, and which is effective in the treatment or prophylaxis of inflammatory conditions of the gastro-intestinal tract.